Obsessive-Compulsive DisorderPhase 1NCT03983031
Rituximab for Obsessive-compulsive Disorder. (RITS-PO-2019)
A Phase 1 study testing Rituximab in people with Obsessive-Compulsive Disorder and Treatment Resistant Disorders, run by Region Örebro County at 2 sites in Sweden.
Trial summary
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Treatment Resistant Disorders
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 2 sitesSweden
- Study dates
- 8 Aug 2019to 31 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient ages 18 to 40 years.
- a duration of illness exceeding 2 years.
- correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S).
- Global Assessment of Functioning (GAF) below 50.
- obsessive-compulsive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- treatment resistance, i.e. failing to remit despite adequate treatments.
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- if female and with any risk for pregnancy, willing to use contraceptives.
- if psychotropic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
- subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
- immunoglobulin levels within the normal range.
Who cannot join
- on-going immunomodulatory treatment.
- pregnancy or breast-feeding.
- weight below 40 kg.
- clinically relevant on-going infection.
- chronic infections .
- positive screening test for hepatitis B, C, HIV or tuberculosis
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- any change of psychotropic medication within the previous 4 weeks
- "much" or "very much" improved already at baseline according to CGI-I.
- severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction.
- unable to make an informed decision to consent to the trial.
- in compulsory treatment.
- treatment with clozapine within the last 2 months.
- previous treatments with immunosuppressive agents.
- malignancy currently or within 2 years prior to inclusion.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Rituximab - Immunotherapy for Obsessive-compulsive Disorder: An Open Pilot Study
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial.
Read the detailed description
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders.
The aim of this study is to investigate whether the psychiatric symptoms of treatment-resistant adult psychiatric patients, diagnosed with obsessive-compulsive disorder (OCD), are significantly improved after treatment with rituximab. The investigator's purpose is to implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable treatment for these patients.
This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the patients will be followed for 1 year.
Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response (defined as clinically relevant reduction in the validated measure Y-BOCS). Other outcomes are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and change in Personal and Social Performance Scale measuring overall disability.
- Being tested
- Rituximab
- Keywords
- Immunopsychiatry, pediatric acute-onset neuropsychiatric syndrome
- Medical subject headings
- Obsessive-Compulsive Disorder, Pediatric acute-onset neuropsychiatric syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown obsessive- compulsive scale (Y-BOCS)
Y-BOCS maps symptoms and measures severity of obsessive-compulsive symptoms by a clinician. Y-BOCS has a range between 0 and 40 points, higher scores denotes worse symptoms. Outcome is measured as change in Y-BOCS score from baseline. At least 35% reduction in the score since baseline is defined as a response.
Measured: week 20
Secondary outcomes (6)
Personal and Social Performance Scale (PSP)
Personal and Social Performance Scale (PSP) gives a score for disability. The PSP is a 100-point single-item rating scale (range 1-100), subdivided into 10 equal intervals. Lower scores denote lower functioning. The ratings are based mainly on the assessment of patient's functioning in four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours. Change in score between enrolment and week 20 will be measured.
Measured: week 20
Clinical Global Impression-severity (CGI-S) scale
CGI-S is a clinician rated measure of overall clinical severity that is rated on a scale between 1 and 7. A person with no clinical complaints or problems will get a score of 1. The score 7 indicates the highest level of severity is phrased as "Among the most extremely ill patients".
Measured: week 20
Clinical Global Impression-Improvement (CGI-I) in relation to inflammatory markers
Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Change in inflammatory markers in blood (gene expression and proteins) towards normality, in relation to clinical response (assessed by the clinician) will be measured.
Measured: week 20
Clinical Global Impression-Improvement (CGI-I). Proportion of responders.
Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. If the mean value of these three is below 2.5 then the patient will be regarded as a responder (representing much or very much improved since baseline).
Measured: week 20
Clinical Global Impression-Improvement (CGI-I).
Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. Range 3-21. A lower score depicts larger improvement.
Measured: week 20
Adverse event: Any Adverse Reactions (AAR). Safety and tolerability of Rituximab
Any Adverse reactions (AAR) is a rating scale developed for this study and is not a validated questionnaire. It consists of a list of 26 symptoms. AAR maps adverse events related to rituximab treatment. These items are assessed for severity on a Likert scale (4 levels: none; mild; moderate; severe) and frequency (3 levels: occasionally; daily; several times daily). AAR is assessed by the clinician. An adverse event scale was required as an outcome measure by the Swedish Medical Products Agency.
Measured: week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start8 Aug 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Susanne Bejerot, Region Örebro County
- Investigators
- Susanne Bejerot, MD, Principal investigator, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983031
- Sponsor's protocol ID
- EudraCT Number: 2018-004619-28
- Status last verified
- May 2022
- First submitted
- 30 May 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Details that can identify the patients will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab - Immunotherapy for Obsessive-compulsive Disorder: An Open Pilot Study
- ClinicalTrials.gov ID
- NCT03983031
- Acronym / sponsor ID
- EudraCT Number: 2018-004619-28
- Keywords
- Immunopsychiatry, pediatric acute-onset neuropsychiatric syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial.
Detailed description
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders.
The aim of this study is to investigate whether the psychiatric symptoms of treatment-resistant adult psychiatric patients, diagnosed with obsessive-compulsive disorder (OCD), are significantly improved after treatment with rituximab. The investigator's purpose is to implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable treatment for these patients.
This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the patients will be followed for 1 year.
Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response (defined as clinically relevant reduction in the validated measure Y-BOCS). Other outcomes are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and change in Personal and Social Performance Scale measuring overall disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- patient ages 18 to 40 years.
- a duration of illness exceeding 2 years.
- correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S).
- Global Assessment of Functioning (GAF) below 50.
- obsessive-compulsive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Key exclusion criteria (14 listed)
- on-going immunomodulatory treatment.
- pregnancy or breast-feeding.
- weight below 40 kg.
- clinically relevant on-going infection.
- chronic infections .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabInfusion | Drug | – |
Primary outcome
Yale-Brown obsessive- compulsive scale (Y-BOCS)
Time frame: week 20
Y-BOCS maps symptoms and measures severity of obsessive-compulsive symptoms by a clinician. Y-BOCS has a range between 0 and 40 points, higher scores denotes worse symptoms. Outcome is measured as change in Y-BOCS score from baseline. At least 35% reduction in the score since baseline is defined as a response.
6 secondary outcomes
Personal and Social Performance Scale (PSP)
Time frame: week 20
Clinical Global Impression-severity (CGI-S) scale
Time frame: week 20
Clinical Global Impression-Improvement (CGI-I) in relation to inflammatory markers
Time frame: week 20
Clinical Global Impression-Improvement (CGI-I). Proportion of responders.
Time frame: week 20
Clinical Global Impression-Improvement (CGI-I).
Time frame: week 20
Adverse event: Any Adverse Reactions (AAR). Safety and tolerability of Rituximab
Time frame: week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No. Details that can identify the patients will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Bejerot, MD principal investigator
Region Örebro län
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rituximab in people with Obsessive-Compulsive Disorder and Treatment Resistant Disorders, run by Region Örebro County at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown obsessive- compulsive scale (Y-BOCS) (time frame: week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.